Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback

The University of Texas System (UT)

Status: Enrolling

Conditions: Feedback; Stroke; Gait Training; Resistance Exercise; Split-belt Treadmill

Treatments: Behavioral: Sensory Feedback Training; Behavioral: Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity; Behavioral: Treadmill Walking with Split-Belt and/or Tied-Belt Conditions

Study type: Interventional

Funder types: Other

Identifiers

NCT07087769

25-0102

Details and patient eligibility

About

This single-session study aims to evaluate a novel gait training protocol that integrates mechanical constraints and sensory feedback to enhance paretic leg propulsion in individuals post-stroke. The study will include 15 individuals who have experienced a stroke and 15 healthy adults, each aged 20 years or older. Participants will walk on both tied-belt and split-belt treadmills under various training conditions, including backward-directed resistance (applied at the pelvis, ankle, or both) and real-time sensory feedback (visual, auditory, or combined). These interventions will be applied individually and in combination to identify the most effective environment for promoting symmetrical gait patterns. Each session will last approximately two hours. The equipment used is non-invasive, and the risk to participants is minimal.

Full description

The purpose of this study is to assess the effectiveness of an integrated gait training paradigm that combines mechanical task constraints and sensory feedback during split-belt treadmill walking to enhance paretic leg propulsion and improve propulsion symmetry in individuals post-stroke. The risks associated with this study are lower than those encountered during daily walking in the community and in typical physical therapy clinics, where patients with physical impairments routinely engage in challenging exercises to improve their abilities. There is a slight possibility of local skin irritation or rash resulting from the non-allergenic adhesive tape or sensor gel used to attach the EMG sensors. This is a rare occurrence and typically resolves within one to two days without medical intervention.

This study will last approximately one to two hours, depending on your condition, and involves a one-time visit.

If you choose to participate in this study, the participant will be asked to:

1. Sign a consent form approved by the University of Texas Medical Branch IRB, outlining the study's purpose, procedures, benefits, risks, and policies.
2. Share medical history and well-being, and have weight, height, and heart rate (via smartwatch) monitored.
3. Assess your walking capacity.
4. Assess the Optimal Gait Training Protocol using Treadmill, Sensory Feedback, and Mechanical task constraints.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Aged 20 years or older

For stroke group: clinical diagnosis of stroke at least 1 month prior to participation

Ability to walk at least 10 meters with or without assistive devices

For healthy group: able to walk independently without assistive devices

Exclusion criteria

Life expectancy less than one year

Comatose or unable to follow three-step commands

Amputation of any lower limb

Poorly controlled diabetes (e.g., foot ulceration)

Blindness

Progressive neurological disease

Medically unstable condition

Significant musculoskeletal impairments affecting gait

Congestive heart failure or unstable angina

Peripheral vascular disease

Severe neuropsychiatric conditions (e.g., dementia, cognitive deficits, severe depression)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Gait Training with Combined Sensory Feedback and Mechanical Constraints

Experimental group

Description:

All participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design.

Treatment:

Behavioral: Treadmill Walking with Split-Belt and/or Tied-Belt Conditions

Behavioral: Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity

Behavioral: Sensory Feedback Training